[June 22, 2017] |
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FDA Approves RITUXAN HYCELA (Rituximab and Hyaluronidase Human) for Subcutaneous Injection in Certain Blood Cancers
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),
announced today that the U.S. Food and Drug Administration (FDA)
approved RITUXAN HYCELA™ (rituximab and hyaluronidase human)
for subcutaneous (under the skin) injection for the treatment of adults
with the following blood cancers: previously untreated and relapsed or
refractory follicular lymphoma, previously untreated diffuse large
B-cell lymphoma (DLBCL), and previously untreated and previously treated
chronic lymphocytic leukemia (CLL). This new treatment includes the same
monoclonal antibody as intravenous Rituxan® (rituximab) in
combination with hyaluronidase human, an enzyme that helps to deliver
rituximab under the skin.
"With today's approval of RITUXAN HYCELA, people with three of the most
common blood cancers now have a new treatment option which provides
efficacy comparable with intravenous Rituxan and can be delivered under
the skin in minutes instead of hours through IV infusion," said Sandra
Horning, M.D., chief medical officer and head of Global Product
Development. "People who benefit from Rituxan may receive years of
repeated treatments for their blood cancer, so an option that reduces
the administration time can be important."
The FDA approval is based on results from clinical studies, which
demonstrated that subcutaneous administration of RITUXAN HYCELA resulted
in non-inferior levels of rituximab in the blood (pharmacokinetics) and
comparable clinical efficacy outcomes compared to intravenous Rituxan.
One of the studies showed the majority (77 percent) of patients
preferred RITUXAN HYCELA over intravenous Rituxan, with the most common
reason being that administration required less time in the clinic.
People can only receive RITUXAN HYCELA after at least one full dose of
intravenous Rituxan.
With the exception of local skin (cutaneous) reactions, the incidence
and profile of adverse reactions for RITUXAN HYCELA were comparable with
those for intravenous Rituxan. The most common (=20 percent) adverse
reactions observed with RITUXAN HYCELA in people with follicular
lymphoma were infections, low white blood cell count (neutropenia),
nausea, constipation, cough and fatigue. The most common adverse
reactions in people with DLBCL were infections, neutropenia, hair loss
(alopecia), nausea and low red blood cell count (anemia). The most
common adverse reactions in people with CLL were infections,
neutropenia, nausea, low platelet count (thrombocytopenia), fever
(pyrexia), vomiting and reddening of the skin (erythema) at the
injection site.
RITUXAN HYCELA will be available to people in the United States within
one to two weeks, and intravenous Rituxan will continue to be
available. For those who qualify, Genentech plans to offer patient
assistance programs for people taking RITUXAN HYCELA through Genentech
Access Solutions. Doctors can contact Genentech Access Solutions at
(888) 249-4918. More information is also available at http://www.Genentech-Access.com.
About the RITUXAN HYCELA Clinical Development Program
The approval of RITUXAN HYCELA is based on results from clinical studies
that together represented nearly 2,000 people. The studies were the
following:
-
SABRINA (NCT01200758): Phase III combination with chemotherapy and
maintenance study in previously untreated follicular lymphoma
-
SAWYER (NCT01292603): Phase Ib study in previously untreated chronic
lymphocytic leukemia (CLL)
-
MabEase (NCT01649856): Phase III study in previously untreated diffuse
large B-cell lymphoma (DLBCL)
-
PrefMab (NCT01724021): Phase III patient preference study in
previously untreated follicular lymphoma and DLBCL
About Follicular Lymphoma
Follicular lymphoma is the most common indolent (slow-growing) form of
non-Hodgkin's lymphoma (NHL), accounting for about one in five cases of
NHL. It is considered incurable and relapse is common. In the United
States, it is estimated that more than 14,000 new cases of follicular
lymphoma will be diagnosed in 2017.
About Diffuse Large B-Cell Lymphoma (DLBCL)
DLBCL is the most common form of non-Hodgkin's lymphoma (NHL),
accounting for about one in three cases of NHL. DLBCL is an aggressive
(fast-growing) type of NHL. As many as 40 percent of patients will
relapse, at which point their prognosis is poor. In the United States,
it is estimated that more than 24,000 new cases of DLBCL will be
diagnosed in 2017.
About Chronic Lymphocytic Leukemia (CLL)
CLL is the most common type of adult leukemia, and in 2017, it is
estimated there will be more than 20,000 new cases of CLL diagnosed in
the United States. Although signs of CLL may disappear for a period of
time after initial treatment, the disease is considered incurable and
many people will require additional treatment due to the return of
cancerous cells.
About Genentech Access Solutions
Access Solutions is part of Genentech's commitment to helping people
access the Genentech medicines they are prescribed, regardless of their
ability to pay. The team of in-house specialists at Access Solutions is
dedicated to helping people navigate the access and reimbursement
process, and to providing assistance to eligible patients in the United
States who are uninsured or cannot afford the out-of-pocket costs for
their medicine. To date, the team has helped more than 1.5 million
patients access the medicines they need. Please contact Access Solutions
(866) 4ACCESS/(866) 422-2377 or visit http://www.Genentech-Access.com for
more information.
About RITUXAN HYCELA
RITUXAN HYCELA is a combination of rituximab and Halozyme Therapeutics'
proprietary hyaluronidase human. Rituximab is the same monoclonal
antibody in intravenous Rituxan and is designed to attach to CD20, a
protein found on certain types of B-cells. It is thought to work by
attacking targeted cells together with the body's immune system.
Halozyme's hyaluronidase human is a well-established enzyme that
facilitates the delivery of a large volume of medicine under the skin.
RITUXAN HYCELA can be administered in five to seven minutes, compared to
1.5 hours or more for intravenous Rituxan. Patients should be observed
for at least 15 minutes following RITUXAN HYCELA. All patients must
first receive at least one full dose of Rituxan by intravenous infusion
without severe adverse reactions before they can receive RITUXAN HYCELA
due to the higher risk of certain severe adverse reactions during the
first infusion.
Rituxan was discovered by Biogen and is part of a collaboration between
Genentech and Biogen in the United States.
RITUXAN HYCELA Indications
RITUXAN HYCELA™ (rituximab/hyaluronidase human) is a prescription
medicine used to treat adults with:
-
Follicular Lymphoma (FL) as a single-agent therapy in patients whose
disease recurred or did not respond to initial treatment
-
Follicular Lymphoma as an initial treatment with chemotherapy and, in
patients whose initial treatment was successful, as a single-agent
follow-up therapy
-
Follicular Lymphoma as a single-agent follow-up therapy for patients
who did not progress on initial treatment with CVP chemotherapy
-
Diffuse Large B-Cell Lymphoma (DLBCL) as an initial treatment in
combination with CHOP or other anthracycline-based chemotherapy
regimens
-
Chronic Lymphocytic Leukemia (CLL) in combination with FC chemotherapy
as an initial treatment or as a treatment after disease has recurred
Patients can only receive RITUXAN HYCELA after at least one full dose
of intravenous (IV) Rituxan® (rituximab). Read
the IV Rituxan Medication Guide for more information about sever
infusion reactions, which usually happen during the first dose with IV
Rituxan.
RITUXAN HYCELA is not for use to treat medical conditions other than
cancers.
It is not known if RITUXAN HYCELA is safe and effective in children.
Important Safety Information
RITUXAN HYCELA can cause serious side effects that can lead to
death, including:
-
Severe skin and mouth reactions: Patients must tell their
healthcare provider or get medical help right away if they get any of
these symptoms at any time during treatment with RITUXAN HYCELA:
painful sores or ulcers on the skin, lips, or in the mouth; blisters;
peeling skin; rash or pustules.
-
Hepatitis B virus (HBV) reactivation: Before a patient receives
RITUXAN HYCELA, the patient's doctor will do blood tests to check for
HBV infection. If the patient has had hepatitis B or is a carrier of
hepatitis B virus, receiving RITUXAN HYCELA could cause the virus to
become an active infection again. Hepatitis B reactivation may cause
serious liver problems including liver failure and death. The
patient's healthcare provider will monitor for hepatitis B infection
during and for several months after the patient stops receiving
RITUXAN HYCELA. Patients must tell their healthcare provider right
away if they get worsening tiredness, or yellowing of the skin or
white part of the eyes during treatment with RITUXAN HYCELA.
-
Progressive Multifocal Leukoencephalopathy (PML): PML is a
rare, serious brain infection caused by a virus that can happen in
people who receive RITUXAN HYCELA. People with weakened immune systems
can get PML. PML can result in death or severe disability. There is no
known treatment, prevention, or cure for PML. Patients must tell their
healthcare provider right away if they have any new or worsening
symptoms or if anyone close to them notices these symptoms: confusion;
dizziness or loss of balance; difficulty walking or talking; decreased
strength or weakness on one side of the body; vision problems, such as
blurred or loss of vision.
-
Serious allergic reactions and other severe reactions:
Serious
allergic reactions, and reactions due to release of certain substances
by the body that can lead to death, can happen with rituximab
products, including RITUXAN HYCELA.
Skin reactions
at or near the injection site (local), including injection site
reactions can happen with RITUXAN HYCELA. Symptoms at or near the
injection site may include: pain, swelling, hardness, redness,
bleeding, itching, and rash. These reactions sometimes happen more
than 24 hours after an injection of RITUXAN HYCELA.
Patients
must tell their healthcare provider or get medical help right away if
they get any of these symptoms during or after an injection of RITUXAN
HYCELA: hives (red itchy welts) or rash; itching; swelling of the
lips, tongue, throat, or face; sudden cough; shortness of breath,
difficulty breathing, or wheezing; weakness; dizziness or feeling
faint; palpitations (feeling the heart is racing or fluttering); chest
pain; fever; chills or shaking chills.
What are possible side effects of RITUXAN HYCELA?
RITUXAN HYCELA can cause serious side effects, including:
-
Tumor Lysis Syndrome (TLS): TLS is caused by the fast breakdown
of cancer cells. TLS can cause the patient to have kidney failure, the
need for dialysis treatment, and an abnormal heart rhythm. TLS can
happen within 12 to 24 hours after an injection of RITUXAN HYCELA. The
patient's healthcare provider may do blood tests to check for TLS. The
patient's healthcare provider may give medicine to help prevent TLS.
Patients must tell their healthcare provider right away if they have
any of the following signs or symptoms of TLS: nausea, vomiting,
diarrhea, or lack of energy.
-
Serious Infections: Serious infections can happen during and
after treatment with RITUXAN HYCELA and can lead to death. Rituximab
products can increase the risk of getting infections and can
lower the ability of the immune system to fight infections. Types of
serious infections that can happen with RITUXAN HYCELA include
bacterial, fungal, and viral infections. After receiving RITUXAN
HYCELA, some people have developed low levels of certain antibodies in
their blood for a long period of time (longer than 11 months). Some of
these people with low antibody levels developed infections. Patients
must tell their healthcare provider right away if they have any
symptoms of infection: fever; cold symptoms, such as runny nose or
sore throat that do not go away; flu symptoms, such as cough,
tiredness, and body aches; earache or headache; pain during urination;
white patches in the mouth or throat; cuts, scrapes, or incisions that
are red, warm, swollen, or painful.
-
Heart Problems: RITUXAN HYCELA may cause chest pain, irregular
heartbeats, and heart attack. The patient's healthcare provider may
monitor the patient's heart during and after treatment with RITUXAN
HYCELA if they have symptoms of heart problems or have a history of
heart problems. Patients must tell their healthcare provider right
away if they have chest pain or irregular heartbeats during treatment
with RITUXAN HYCELA.
-
Kidney Problems: RITUXAN HYCELA can cause severe kidney
problems that can lead to death. The patient's healthcare provider
should do blood tests to check how well the patient's kidneys are
working.
-
Stomach and serious bowel problems that can sometimes lead to
death: Bowel problems, including blockage or tears in the bowel,
can happen if the patient receives RITUXAN HYCELA with chemotherapy
medicines. Patients must tell their healthcare provider right away if
they have severe stomach-area (abdomen) pain or repeated vomiting
during treatment with RITUXAN HYCELA.
The patient's healthcare provider will stop treatment with RITUXAN
HYCELA if the patient has severe, serious, or life-threatening side
effects.
The most common side effects of RITUXAN HYCELA in people with:
-
FL: infections, low white blood cell count, nausea,
constipation, cough, and tiredness.
-
DLBCL: infections, low white blood cell count, loss of hair,
nausea, and low red blood cell count.
-
CLL: infections, low white blood cell count, nausea, low
platelet count, fever, vomiting, and injection site redness.
Additional Important Safety Information
Before receiving RITUXAN HYCELA, patients must tell their healthcare
provider about all of their medical conditions, including if they:
-
Have had a severe reaction to a rituximab product or RITUXAN HYCELA.
-
Have had a recent vaccination or are scheduled to receive
vaccinations. Patients should not receive certain vaccines before or
during treatment with RITUXAN HYCELA.
-
Are pregnant, plan to become pregnant, are breastfeeding, or plan to
breastfeed. Patients should talk to their healthcare provider about
the risks to their unborn baby if they receive RITUXAN HYCELA during
pregnancy. Females who are able to become pregnant should use
effective birth control (contraception) during treatment with RITUXAN
HYCELA and for 12 months after the last dose of RITUXAN HYCELA.
Patients should talk to their healthcare provider about effective
birth control. It is not known if RITUXAN HYCELA passes into the
patient's breast milk. Patients must not breastfeed during treatment
and for at least 6 months after receiving their last dose of
RITUXAN HYCELA.
These are not all of the possible side effects with RITUXAN HYCELA.
Patients should call their doctor for medical advice about side effects.
Please see the full Prescribing
Information, including BOXED WARNINGS and Medication Guide,
for additional Important Safety Information.
Report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch.
Report side effects to Genentech at (888) 835-2555.
Rituxan Indications
Rituxan® (rituximab) injection, for intravenous use, is
indicated for the treatment of patients with:
-
Low-grade or follicular CD20-positive non-Hodgkin's lymphoma as a
single-agent therapy in patients whose disease recurred or did not
respond to initial treatment
-
Follicular CD20-positive non-Hodgkin's lymphoma as an initial
treatment with chemotherapy, and in patients whose initial treatment
was successful, as a single-agent follow-up therapy
-
Low-grade CD20-positive non-Hodgkin's lymphoma as a single-agent
follow-up therapy for patients who did not progress on initial
treatment with CVP chemotherapy
-
CD20-positive diffuse large B-cell non-Hodgkin's lymphoma as an
initial treatment in combination with CHOP chemotherapy
-
CD20-positive chronic lymphocytic leukemia in combination with FC
chemotherapy as an initial treatment or as a treatment after disease
has recurred
People with serious infections should not receive Rituxan.
It is not known if Rituxan is safe or effective in children.
Important Safety Information:
Patients must tell their doctor right away about any side effects they
experience. Rituxan can cause serious side effects that can lead to
death, including:
-
Infusion Reactions: may occur during or within 24 hours of the
infusion. The patient's doctor should give the patient medicines
before their treatment. Symptoms can include hives, rash, itching,
facial or oral swelling, sudden cough, shortness of breath, difficulty
breathing, weakness, dizziness, feeling faint, racing heart, or chest
pain.
-
Severe Skin and Mouth Reactions: symptoms can include painful
sores, ulcers, or blisters on the skin, lips or mouth; peeling skin;
rash; or pustules.
-
Hepatitis B Virus (HBV) Reactivation: may cause serious liver
problems including liver failure and death. If patients have had
hepatitis B or are carriers of HBV, receiving Rituxan could cause the
virus to become an active infection again. Patients should not receive
Rituxan if they have active HBV liver disease. The patient's doctor
will do blood tests to check for HBV infection prior to treatment and
will monitor the patient during and for several months following their
treatment.
-
Progressive Multifocal Leukoencephalopathy (PML): a rare,
serious brain infection that can lead to severe disability and death
and for which there is no known prevention, treatment or cure.
Symptoms can include difficulty thinking, loss of balance, changes in
speech or walking, weakness on one side of the body, or blurred or
lost vision.
What are the additional possible serious side effects of Rituxan?
Patients must tell their doctor right away about any side effects they
experience. Rituxan can cause serious side effects that can lead to
death, including:
-
Tumor Lysis Syndrome (TLS): may cause kidney failure and the
need for dialysis treatment, abnormal heart rhythm, and can lead to
death. The patient's doctor may give the patient medicines before
their treatment to help prevent TLS.
-
Serious Infections: can happen during and after treatment and
can lead to death. These infections may be bacterial, fungal, or
viral. Symptoms can include fever; cold or flu symptoms; earache or
headache; pain during urination; white patches in the mouth or throat;
cuts or scrapes that are red, warm, swollen or painful.
-
Heart Problems: symptoms can include chest pain and irregular
heartbeats that may require treatment. The patient's doctor may need
to stop their treatment.
-
Kidney Problems: the patient's doctor should do blood tests to
check how well the patient's kidneys are working.
-
Stomach and Serious Bowel Problems: can include blockage or
tears in the bowel that can lead to death. Stomach area pain during
treatment can be a symptom.
-
Low Blood Cell Counts: the patient's blood cell counts may be
monitored during treatment.
The most common side effects of Rituxan are infusion reactions, chills,
infections, body aches, tiredness, and low white blood cells.
Other side effects with Rituxan include:
-
aching joints during or within hours of receiving an infusion
-
more frequent upper respiratory tract infection
Patients must tell their doctor if they are pregnant, plan to become
pregnant, or are breastfeeding. It is not known if Rituxan may harm the
patient's unborn baby or pass into the patient's breast milk. Women
should use birth control while using Rituxan and for 12 months after
treatment.
Patients must tell their doctor about any side effect that bothers them
or that does not go away. These are not all of the possible side effects
of Rituxan. For more information, patients should ask their doctor or
pharmacist.
Please see the Rituxan full Prescribing Information, including BOXED
WARNINGS and the Medication Guide, for additional Important Safety
Information at http://www.Rituxan.com.
Report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch.
Report side effects to Genentech at (888) 835-2555.
About Genentech In Hematology
For more than 20 years, Genentech has been developing medicines with the
goal to redefine treatment in hematology. Today, we're investing more
than ever in our effort to bring innovative treatment options to people
with diseases of the blood. In addition to approved medicines,
Genentech's pipeline of investigational hematology medicines includes an
anti-CD79b antibody drug conjugate (polatuzumab vedotin/RG7596) and a
small molecule antagonist of MDM2 (idasanutlin/RG7388). Genentech's
dedication to developing novel medicines for blood diseases expands
beyond oncology, with the development of the investigational hemophilia
A treatment emicizumab. For more information visit http://www.gene.com/hematology.
About Genentech
Founded more than 40 years ago, Genentech is a leading biotechnology
company that discovers, develops, manufactures and commercializes
medicines to treat patients with serious or life-threatening medical
conditions. The company, a member of the Roche Group, has headquarters
in South San Francisco, California. For additional information about the
company, please visit http://www.gene.com.
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